Protocol For Use of TheraSphere® For Treatment of Unresectable Hepatocellular Carcinoma
TheraSphere is a medical device containing yttrium-90 (Y-90), a radioactive material that
has been used to treat liver tumors. When Y-90 is put into microscopic glass beads, called
microspheres, it can be injected directly into the liver by vein. This allows a large dose
of radiation to be delivered directly to the tumor, which lowers the risk of experiencing
toxic radiation side effects from the radiation to in other parts of the body, or to healthy
liver tissue. The radiation from TheraSphere treatment stays in the body and begins to lose
its effect within 12 days, due to physical decay (please refer to the package insert for
more information for more information regarding this). The glass microspheres will stay in
the body from that point on, but should not cause any health problems.
All visits and procedures related to the TheraSphere treatment will be performed on an
outpatient basis. About 2 weeks before the treatment begins, a small tube (catheter) will
be inserted into a vein that goes to the liver, usually in the thigh.
TheraSphere (microspheres filled with Y-90 as described above) will be injected into the
tumor in the liver through a catheter that you have already had placed into an artery during
an earlier procedure.
You will receive at least 1 TheraSphere injection while you are receiving the treatment. If
the doctor thinks it is needed, you will have a second injection about 1 month later. The
number of TheraSphere injections you will receive will depend on the size and location of
the tumors. The injection should take about 5 minutes to complete each time.
After receiving the TheraSphere injection, you will stay at the hospital for several hours
so that the staff can check you for possible side effects. If you experience any serious
problems or complications after receiving the injection, you may be admitted to the hospital
for observation and possible additional treatment.
Length of Treatment:
You will continue to receive the HUD treatment indefinitely.
TheraSphere is a humanitarian use device that is approved by the FDA for the treatment of
rare disorders affecting less than 4,000 people in the U.S. each year.
All of the tests and procedures that will be performed as part of this treatment protocol
are considered to be standard care, including the TheraSphere.
Up to 200 patients will receive the treatment. All will be enrolled at M.D. Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Survival Associated With TheraSphere Treatment
3-6 weeks post treatment
Armeen Mahvash, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|